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TDMS Study 05092-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/12/94   
EXP: 05092                     O-NITROANISOLE                  TIME: 16:31:13   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C60388   
CONT: N01-ES-45038                                             CAS: 0091-23-6   
PATHOLOGIST: R. THOMPSON                     S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/12/94  
EXP: 05092                     O-NITROANISOLE                  TIME: 16:31:13  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: C60388  
CONT: N01-ES-45038                                             CAS: 0091-23-6  
PATHOLOGIST: R. THOMPSON                     S. EUSTIS                         

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      484   496   575   599   603   613   617   633   668   669                 |
 |      669   669   673   676   683   695   696   716                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0%     15 SSAC                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   457   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0222%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      63    423   511   551   559   589   638   641   642   647                 |
 |      647   655   681   682   687   719                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0222% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0666%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      437   533   557   558   596   604   632   637   641   646                 |
 |      646   647   657   667   667   667   669   679   683   686                 |
 |      687   695   716   718   722   722                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0666% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.200%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 41     CENSORED DEATHS 0    TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      481   491   502   511   518   518   529   554   561   563                 |
 |      589   589   589   604   604   613   621   632   632   632                 |
 |      632   633   641   642   646   646   655   655   658   663                 |
 |      667   669   686   686   687   687   695   697   697   699                 |
 |      715                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.200%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 1      CENSORED DEATHS 9    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      106                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   458   458                       |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  84.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0222%    |    98.0  98.0  98.0  98.0  96.0  96.0  94.0  88.0  76.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0222%    |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  88.0  74.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0 100.0  98.0  86.0  70.0  40.0  18.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0  90.0  90.0  90.0  90.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0.0%        0.0%        0.0222%     0.0222%     0.0666%     0.0666%     0.200%      0.200%   |
 |                                            15 SSAC                 15 SSAC                 15 SSAC                 15 SSAC  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.0%        0.0%       68.0%        0.0%       48.0%        0.0%       18.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P<0.001      -----      P=0.893N     -----      P=0.172      -----      P<0.001     P=0.371  |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       635.2          .        583.4          .        645.0          .        619.2       106.0    |
 |NATURAL DEATHS (C)      |       (15.4)      (  . )      (39.5)      (  . )      (12.9)      (  . )      (10.2)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       694.6       457.0       681.7       457.1       684.8       457.1       638.8       421.7    |
 |(STANDARD ERROR)        |       ( 8.4)      ( 0.3)      (15.7)      ( 0.3)      ( 8.9)      ( 0.3)      (10.2)      (35.1)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   480   494   518   613   613   634   663   669   673                 |
 |      687   687   694   700   700   700   723                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0%    15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0222%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      333   436   533   598   646   672   723   727   727                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0222% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   457   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0666%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      302   416   459   525   533   536   563   571   571   589                 |
 |      610   613   630   632   633   641   646   658   683   683                 |
 |      695   710   716   719                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0666% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   458   458                 |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.200%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      386   476   500   521   557   604   604   613   631   634                 |
 |      647   655   663   687   716   720   722                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.200%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 1      CENSORED DEATHS 9    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      407                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   458   458   458   458                       |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  92.0  84.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0222%    |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  92.0  90.0  82.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0222%    |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0  98.0  96.0  94.0  88.0  80.0  64.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0  98.0  96.0  92.0  86.0  74.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0  90.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0.0%        0.0%        0.0222%     0.0222%     0.0666%     0.0666%     0.200%      0.200%   |
 |                                            15 SSAC                 15 SSAC                 15 SSAC                 15 SSAC  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%        0.0%       82.0%        0.0%       52.0%        0.0%       66.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.385      -----      P=0.108N    P=1.000N    P=0.149     P=1.000N    P=1.000     P=0.727  |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       628.6          .        599.4          .        597.3          .        608.0       407.0    |
 |NATURAL DEATHS (C)      |       (21.8)      (  . )      (46.8)      (  . )      (20.5)      (  . )      (22.7)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       694.2       457.1       704.9       457.0       665.2       456.8       687.2       452.1    |
 |(STANDARD ERROR)        |       ( 9.9)      ( 0.3)      (10.7)      ( 0.3)      (13.5)      ( 0.2)      (11.1)      ( 5.0)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.0%     15 SSAC = 2
                                                        0.0222%          = 3
                                                        0.0222% 15 SSAC  = 4
                                                        0.0666%          = 5
                                                        0.0666% 15 SSAC  = 6
                                                        0.200%           = 7
                                                        0.200%  15 SSAC  = 8

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1         3       8                                                3 5      211      5
      |                                                                    3          173    5 35  1   1
P     |                   8                                                         8   77  7  33     31111 53
E     |                                                                                     7   77        1 15    1
R  80 +                                                                                          7    7      333
C     |                                                                                               7 7     53  113
E     |                                                                                                 777        1131  33
N     |                                                                                                   7 7     555 1  11
T  60 +                                                                                                             555
      |                                                                                                     77        5  5
S     |                                                                                                      777         55
U     |
R  40 +                                                                                                        7 77
V     |                                                                                                           7 7
I     |                                                                                                             777
V     |
A  20 +                                                                                                               7  77
L     |
      |
      |
    0 +                                                                             2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 55 obs hidden.

                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.0%    15 SSAC  = 2
                                                        0.0222%          = 3
                                                        0.0222% 15 SSAC  = 4
                                                        0.0666%          = 5
                                                        0.0666% 15 SSAC  = 6
                                                        0.200%           = 7
                                                        0.200%  15 SSAC  = 8

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1                                               5    3        7  85  1   2 71
      |                                                                   5  3   5 71 17 1 5 3         3
P     |                                                                  8       8       1 5 5  75     371  1 3   3       3
E     |                                                                                          55     77  1    11
R  80 +                                                                                           5   5  5  7 77  11 1    3
C     |                                                                                                  5 55  7 7   11
E     |                                                                                                     555      71  71
N     |                                                                                                       55    5     1
T  60 +                                                                                                             5 5 5
      |                                                                                                                 55
S     |                                                                                                                  55
U     |
R  40 +
V     |
I     |
V     |
A  20 +
L     |
      |
      |
    0 +                                                                          2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 43 obs hidden.